Systems And Methods For Removing Ingested Material From A Stomach

ABSTRACT

When a patient is fitted with an external gastrostomy connection to the stomach, ingested food can be removed through the gastrostomy connection using a pump-based or siphon-based system to achieve weight loss. The process of removing ingested food can be improved by alternating the infusion of liquid into the stomach with the removal of material from the stomach. Optionally, stomach acid may be captured and returned to the stomach. Optionally, nutritional supplements or medicines may be added to the infused liquid. Optionally, a flush mount connectorized system with a built in valve may be used to simplify the interface with the gastrostomy hardware that remains installed in the patient. Optionally, the system may be configured to disable itself from further use after a triggering event (e.g., the passage of time or a predetermined number of uses) has occurred.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. provisionalapplication No. 60/821,333, filed Aug. 3, 2006, U.S. patent applicationSer. No. 11/675,525, filed Feb. 15, 2007, U.S. patent application Ser.No. 11/675,527, filed Feb. 15, 2007, and U.S. patent application No.11/675,544, filed Feb. 15, 2007.

BACKGROUND OF THE INVENTION

The invention generally relates to removing ingested material from astomach of a patient, and the primary intended fields of the inventionare facilitating weight loss and preventing weight gain.

BRIEF SUMMARY OF THE INVENTION

In one aspect of the invention, food that has been ingested is removedfrom the patient's stomach via a gastrostomy tube using a siphon action.In another aspect of the invention, food that has been ingested isremoved from the patient's stomach via a gastrostomy tube, and theremoval of food is facilitated by infusing fluid into the patient'sstomach via the gastrostomy tube. In another aspect of the invention,matter that has been ingested is removed from the patient's stomach viaa gastrostomy tube, and stomach acid is separated from the removedmatter and returned to the patient's stomach. In another aspect of theinvention, matter that has been ingested is removed from the patient'sstomach via a gastrostomy tube, and the system is configured to disableitself from further use after the occurrence of a triggering event(e.g., the passage of time or a predetermined number of uses).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of an embodiment of the inventionfor removing ingested material from a patient's stomach.

FIG. 2 is a schematic representation of a first embodiment forimplementing the system shown in FIG. 1.

FIG. 3 is a schematic representation of a second embodiment forimplementing the system shown in FIG. 1.

FIG. 4 shows a side view of a third embodiment for implementing thesystem depicted in FIG. 1.

FIG. 5A shows an isometric view of the FIG. 4 embodiment.

FIG. 5B shows a front view of internal components of the FIG. 4embodiment.

FIG. 5C shows a back view of internal components of the FIG. 4embodiment.

FIG. 6A shows an isometric view of another embodiment for implementingthe system depicted in FIG. 1.

FIG. 6B shows a front view of internal components of the FIG. 6Aembodiment.

FIG. 7A schematically shows an embodiment of a system for removingingested material from a stomach, filtering select gastric contents, andreturning filtered fluid to the stomach.

FIG. 7B schematically shows an embodiment of a system for removingingested material from a stomach, filtering select gastric contents, andreturning filtered fluid and water to the stomach.

FIG. 8A shows a patient with a skin connector coupled with a gastrostomytube that is inserted into the stomach.

FIG. 8B shows a view of the skin connector prior to mating with a tubeconnector.

FIG. 8C shows a view of the skin connector mated with a tube connector.

FIGS. 9A, 9B, and 9C show side, top, and isometric views of a skinconnector valve assembly for the embodiment shown in FIGS. 8A-8C.

FIGS. 10A, 10B, and 10C show side, top, and isometric views of anassembled flush skin connector for the embodiment shown in FIGS. 8A-8C.

FIGS. 11A, 11B, 11C, and 11D show side, top, and isometric views of askin connector flange assembly for the embodiment shown in FIGS. 8A-8C.

FIG. 12A is an exploded view of the rotational valve assembly for theembodiment shown in FIGS. 8A-8C.

FIG. 12B is an exploded view of another embodiment of the rotationalvalve assembly for the embodiment shown in FIGS. 8A-8C.

FIG. 13A shows a bottom view of a tube connector assembly for theembodiment shown in FIGS. 8A-8C.

FIG. 13B shows a side view of a tube connector assembly for theembodiment shown in FIGS. 8A-8C.

FIGS. 14A and 14B show the tube connector connected to the skinconnector of the embodiment shown in FIGS. 8A-8C, in the closed andopened positions, respectively.

FIG. 15 shows the embodiment shown in FIGS. 8A-8C being used by apatient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

This application discloses methods and apparatuses for removing materialfrom a patient. In the exemplary embodiment disclosed herein, themethods and apparatuses are used for removing ingested material from apatient's stomach in patients that have been fitted with a gastrostomytube. Examples of suitable gastrostomy tubes are described in U.S.Patent Application Publication Nos. US 2004/0220516, US 2005/0277900 andUS 2005/0283130, each of which is incorporated herein by reference.Additional gastrostomy tubes are described in U.S. Provisional PatentApplication 60/806,556, which is also incorporated herein by reference.

The primary contemplated use for the methods and apparatuses describedherein is achieving weight loss in obese or overweight people. Althoughthe exemplary embodiments are described herein in the context ofremoving ingested material from a patient's stomach, the methods andapparatus can also be used for removal of a variety of fluids from apatient (with, when necessary, appropriate modifications that will beapparent to persons skilled in the relevant arts).

FIG. 1 shows a patient 10 that is fitted with a gastrostomy tube with asystem for removing ingested material from a stomach. An example of sucha gastrostomy tube 45 is shown in FIG. 8A. The gastrostomy tube 45interfaces with the outside world via connection 14, so the systemcommunicates with the gastrostomy tube 45 through that connection. Thesystem preferably includes an assembly 16 for infusing fluid into thestomach through the connection 14 in a manner permitting the fluid tomix with the ingested material or, for use in priming the system whendesired, and a drain line 18 for draining content of the stomachreceived from the connection 14.

The drain line 18 may be in communication with the assembly 16, asshown. In alternative embodiments (not shown), the drain line 18 may beimplemented independent of the assembly 16. For example, one line may beused to drain content of the stomach through the connection 14 andanother line may infuse the fluid into the stomach through theconnection. The system preferably includes a patient line 20 incommunication with the assembly 16 and the connection 14 to the patient10, and the patient line 20 preferably has a suitable connector at itsupper end that mates with the connection 14. In alternative embodiments(not shown), the assembly 16 may be coupled directly to the externalgastrostomy connection 14 without using an intermediate patient line.The assembly 16 may include a fluid source and may optionally include avalve arrangement and/or one or more pumps as described in more detailbelow.

In operation, the system is connected up to the connection 14 to removethe contents of the stomach via the connection. In some embodiments, theremoval may be accomplished by pumping the stomach contents out via theconnection 14. In alternative embodiments, this removal is accomplishedby setting up a siphon system so that the contents of the stomach can besiphoned out of the patient's stomach.

In siphon-based systems, the drain line 18 preferably has a length inexcess of 25 cm in order to create a pressure differential that issufficient to form an effective, efficient siphon that can gently andpassively drain content from the stomach. However, in alternativeembodiments, the drain line 18 can be of a length less than 25 cm. Notethat when the patient is standing, the overall siphon system is measuredfrom the lowest point in the tube or line that is inserted into thestomach to the end of the drain line 18. Optionally, the siphon systemmay be designed to be long enough to run from the stomach of a standingpatient to a position proximate to a floor-based disposal arrangement,such as a toilet or waste container. The drain line may include a siphontube made from flat, collapsible tubing or other flexible tubing.Silicon is a suitable material for the patient line 20 and the drainline 18. However, in alternative embodiments, the patient line 20 can bemade from any material known and used in the art of tubes or anymaterial that could be used to impart the necessary function of thepatient line 20.

In some situations (e.g., when the patient has drank a significantamount of liquids), an effective siphon effect can be achieved withoutinfusing any liquids into the patient's stomach. In other situations,however, it may be necessary to add additional fluid into the patient'sstomach to help start up the siphoning, so that the ingested materialcan be effectively removed from the patient's stomach. This may be doneby having the patient drink additional fluids or by infusing additionalfluid into the stomach through the connection 14.

In many cases, a single siphoning operation will be insufficient toremove the desired amount of ingested material from the patient'sstomach. In those cases, it is desirable to introduce additional liquidinto the stomach so that one or more additional siphoning operations canbe done. A preferred approach for introducing additional liquid into thestomach is by infusing the liquid into the stomach through theconnection 14. For example, after eating a meal and drinking liquids,the subject may attach the device to the connection 14, and siphon out alarge portion of the stomach contents (e.g., fluid with solidparticulate, pieces, and/or chunks of food). For a typical meal, thevolume of this initial siphoning operation may be on the order of 750cc, but that number will of course vary based on the volume andcharacteristics of the ingested meal. Once the siphon effect stops, thesubject infuses water back through the connection 14 into the stomachand then initiates another siphoning operation to remove the infusedwater, which will carry out additional solid food particles, piecesand/or chunks. The infusing and siphoning steps may then be repeateduntil the desired amount of ingested material is removed from thestomach. An example of a suitable volume for infusing into the stomachduring the infusing step is 180 cc, although any other volume may beused.

Note that the methods described herein are preferably used to remove asignificant portion of the food that the patient has ingested (e.g.,between 30 and 60%, and more preferably between 40 and 50%, of theingested food). Removing all the food that was ingested by the patientis not preferred and will usually be impractical. Examples of systemsthat implement both the removal of ingested material and the infusion offluids are described below.

FIG. 2 schematically shows a first embodiment of a system foralternately removing ingested material from a stomach and infusing fluidinto the stomach. The fluid may be any biocompatible fluid such as wateror saline, and may optionally include one or more nutrients and/ormedications. As shown, the assembly 16 includes a fluid source 22 and avalve arrangement 24 in communication with the fluid source 22, thedrain line 18, and the patient line 20. The valve arrangement 24 mayinclude one or more valves and any type of valve, such as, but notlimited to, check valves, blade occluder and diverter valves. Forexample, the valve arrangement 24 may be implemented using a single3-way valve with two operating positions—one position that opens a pathbetween the patient line 20 and the drain line 18, and another positionthat opens a path between the fluid source 22 and the patient line 20.Alternatively, the valve arrangement 24 may be implemented using twovalves—a first valve used to open a path between the patient line 20 andthe drain line 18 and a second check valve used to open a path betweenthe fluid source 22 and the patient line 20 when fluid is pumped fromthe fluid source 22 into the patient's stomach via connection 14 (shownin FIG. 1). In operation, the first valve is opened to drain thecontents of the stomach. The first valve is then closed and fluid ispumped from the fluid source 22 to the patient line 20. Optionally, thefirst valve may be closed automatically by the fluid when the fluid ispumped from the fluid source 22. The first valve may then be re-openedto drain content of the stomach when fluid is no longer pumped to thepatient line 20.

Other embodiments may include a plurality of valves, such as shown inFIG. 3. FIG. 3 schematically shows an assembly 16 having a check valve,valve A, in communication with the fluid source 22 and also with twovalves, valve B and valve F. Valve B is in communication with a checkvalve, valve C, which is in communication with the connection 14 (shownin FIG. 1) via the patient line 20. Valve F is in communication with acheck valve, valve E, which is in communication with the drain line 18.Another valve, valve D is in communication with the patient line 20 andthe drain line 18. Valve B and valve F may be coupled, such that valve Bis opened when valve F is closed, and valve F is opened when valve B isclosed. In operation, valve B is opened while valve F is closed. Valve Dmay then be opened to drain the contents of the stomach received fromthe patient line 20. Optionally, the system may be configured so that asfluid is pumped through valve B and valve C, the movement of the fluidcloses valve D and permits the fluid to flow into the stomach throughthe patient line 20. When fluid is no longer pumped through valves B andC, valve D may be activated automatically or manually to re-open todrain content of the stomach. When finished removing content from thestomach, valve D is closed and valve B is closed, which in turn opensvalve F. The fluid may then be pumped through valve A, valve F and valveE to the drain line 18 in order to clean the drain line after use.

Variations on the assembly 16 shown in FIG. 3 may be implemented usingone or more pumps in communication with the valve arrangement 24, thefluid source 22 and/or the drain line 18. For example, a pump may becoupled between the fluid source 22 and the patient line 20 with a checkvalve in communication with the fluid source 22 and the pump and anothercheck valve in communication with the pump and the patient line 20 tofacilitate fluid flow to the connection 14 (shown in FIG. 1). A pump maybe coupled between the patient line 20 and the drain line 18 with acheck valve in communication with the patient line 20 and the pump andanother check valve in communication with the pump and the drain line18. A pump may also be provided by the squeezing of a hand, e.g.,squeezing the fluid source. A combination of two or more pumps may beused, to facilitate fluid flow to the patient line 20, to the drain line18, or both. For example, during operation, if the system becomesclogged with content of the stomach such that the draining and/orinfusing is not functioning properly, a pump may be provided to clearthe obstruction in the patient line 20 and/or the drain line 18. Varioustypes of pumps may also be used, such as, but not limited to, adiaphragm pump, a spring loaded piston pump, a syringe pump, aperistaltic pump, a flexible vein pump, a pneumatically actuated pump ora combination thereof. The pump(s) may be removable from the system suchthat a pump is only provided when necessary.

Referring now to FIGS. 2 and 3, a removable syringe may be provided atan auxiliary port 25 to provide suction for removing clogs from thepatient line 20 and/or drain line 18. Although various configurationshave been discussed for the valves and pumps with respect to FIGS. 2 and3, it will be apparent to those skilled in the art that any number,kind, and/or configuration of valves and pumps may be used.

FIGS. 4 and 5A-5C show an embodiment of a system for removing ingestedmaterial from the stomach. In this embodiment, the system includes thefluid source 22, the drain line 18, and the patient line 20 and alsoincludes an actuation handle 26 for opening and closing a path betweenthe patient line 20 and the drain line 18 and for opening and closing apath between the fluid source 22 and the patient line 20. In operation,the actuation handle 26 may toggle the assembly 16 between two modes, adrain mode and an infusion mode. For example, in the drain mode, theactuation handle 26 may be in its original or un-actuated position whichmay cause the path between the patient line 20 and the drain line 18 tobe opened and the path between the fluid source 22 and the patient line20 to be closed, thus permitting content of the stomach to be drained.When the actuation handle 26 is squeezed or actuated, the actuationhandle 26 causes the path between the patient line 20 and the drain line18 to be closed and the path between the fluid source 22 and the patientline 20 to be opened. The actuation handle 26 causes the fluid source 22to be squeezed or pumped, forcing the fluid out of the fluid source 22,thus allowing fluid to flow into the stomach in the infusion mode. Forexample, a user may squeeze the actuation handle 26 and fluid source 22by hand. When the actuation handle 26 is released, the actuation handle26 is returned to its original position, e.g., by a spring force, suchas an extension spring, causing the path between the patient line 20 andthe drain line 18 to be re-opened and the path between the fluid source22 and the patient line 20 to be re-closed. The actuation handle 26 maycause the various paths to be opened or closed using any of a variety ofapproaches that will be apparent to persons skilled in the relevantarts, e.g. by pressing or pinching the various fluid lines or actuatingvalves.

Still referring to FIGS. 4 and 5A-5C, the system may also include apatient line cap 28 and a patient port plug 30 for when the system isnot in use and removed from the patient. For example, the assembly 16may be removed from the patient line 20 and the patient line cap 28 maybe used to terminate the patient line 20. Similarly, the patient portplug 30 may be used to plug the opening where the patient line 20couples to the assembly 16.

The assembly 16 may also include a rinse slide 32 for opening andclosing a path between the fluid source 22 and the drain line 18. Afterthe system is used to infuse fluid into the stomach and drain contentsout of the stomach, the fluid source 22 may be used to rinse out orclean the patient line 20, the drain line 18 or both. Upon completion ofuse, the actuation handle 26 may be squeezed with the fluid source 22 tocause fluid to flow through and clean the patient line 20. Once thepatient line 20 is clear, the patient line 20 may be clamped while stillholding the actuation handle 26 and the patient line 20 may bedisconnected from the assembly 16. The actuation handle 26 may then bereleased. In order to clean the drain line 18, the rinse slide 32 may beactivated, allowing fluid to flow from the fluid source 22 down thedrain line. When the rinse slide is activated, both valves open andsince the drain line is lower than the fluid source, the fluid flows outof the drain line 18. The actuation handle 26 may then be squeezed withthe fluid source 22, causing fluid to be pumped out of the fluid source22 and through the drain line 18, cleaning the drain line 18.

Referring now to FIG. 4, optionally, the system may include anattachment mechanism 34 such as a belt clip, for attaching the assembly16 to the patient during use of the system. Now referring to FIGS. 4 and5A-5C, the attachment mechanism 34 may be coupled to the assembly 16 atan attachment location 36. The fluid source 22 may be coupled to theassembly 16 at an attachment assembly 38.

FIGS. 6A and 6B depict an alternative assembly 16′ that may be used inplace of the assembly 16 depicted in FIGS. 4 and 5A-5C. In thisembodiment an actuation lever 44 alternately either (a) opens a pathbetween the patient line 20 and the drain line 18 or (b) closes the pathbetween the patient line and the drain line. Referring now to FIG. 6B,when the lever 44 is actuated in this embodiment, it causes the pathbetween the patient line 20 and the drain line 18 to be clamped by clamp49 and the path between the fluid source 22 and the patient line 20 tobe opened. When the fluid source 22 is squeezed while the lever 44 is inan actuated position, fluid from the fluid source 22 will flow through acheck valve, into the patient line and into the stomach. When the lever44 is in a non-actuated position, the path between the patient line 20and drain line 18 is open. Upon squeezing the fluid source 22 in anon-actuated position, water flows from the fluid source 22 through thedrain line 18 and causes a rinsing effect, which obviates the need forthe separate rinse slide. In the illustrated embodiment, the actuationlever 44 may cause the paths to be closed/opened by clamp 49 pressing orpinching on the tubing lines. However, persons skilled in the relevantarts will recognize that alternative approaches for opening and closingthe various fluid flow paths may be substituted by making appropriatemodifications.

Since water bottles may have varied thread designs which would notordinarily mate with conventional female fittings, a universal fluidsource receptacle 46 may optionally be implemented to accept any waterbottle neck, and to lock around the bottle neck flange. Upon actuationthe receptacle releases the flange on the fluid source. This feature mayalso be implemented in the other embodiments described herein.

The system is preferably connected to a gastrostomy tube that haspreviously been installed in a patient (e.g., through the patient'sabdominal wall), with a port that extends out of the patient's body.Preferably, the port is relatively flush with the surface of thepatient's abdomen and has a connector that mates with a mating connectorof the system. A variety of ways to implement such a flush mountconnection interface can be readily envisioned.

FIGS. 8-15 depict one preferred implementation of a flush mountconnection interface. One part of the interface is the “skin connector”60 (shown in FIGS. 9-12) which is an implementation of the connection 14discussed above in connection with FIG. 1, and is affixed to the patientand the gastrostomy tube 45 that resides inside the patient's stomach.This embodiment of the skin connecter 60 includes a rotational valveassembly that controls opening and closing of the pathway into thestomach, as shown in FIGS. 14A-14B. The other part of the interface isthe “tube connector” 65, also shown in FIGS. 14A-14B, which ispositioned at the upper end of the patient line 20 and is designed tomate with the skin-connector 60 with a fluid-tight interface.

FIGS. 9-11 depict a rotational valve assembly 50 that is assembledinside a skin flange 55 to create a flush mount skin connector 60, andFIG. 12A is an exploded view of the rotational valve assembly 50. Threeof the valve assembly components 81, 82, 83 have a thru-hole biased toone quadrant, arranged so that the valve is opened when the thru-holesare aligned and so that the valve is closed when the thru-holes are notaligned. In the preferred embodiment, the size for the entire valveassembly ranges from about 3 cm to about 4 cm in diameter, and the sizefor the thru-holes is about 6-8 mm in diameter. In the valve assembly 50the platform diameter can measure from about 3.5 to about 7 times largerthan the diameter of the thru-hole that passes therethrough. However, inother embodiments, the valve assembly can be proportionally differentsize, either larger or smaller. The valve assembly 50 is preferablyconstructed of top platform 81 and a bottom platform 83, with a layer ofelastomer 82 that is attached to the top platform 81 and sandwichedbetween the top platform and the bottom platform 83 with a force that ishigh enough to prevent leaks, yet low enough to permit rotation of theelastomer 82 with respect to the bottom platform 83. The elastomer isattached to the top platform using any adhesive that would attach thesilicon to the plastic, however, in one embodiment, a primer and a fastcuring adhesive is used. The top platform 81 is preferably made of alubricious plastic for example, acetyl, and in some embodiments,DELRIN®, TEFLON®, polyethylene, etc, can be used, and the bottomplatform 83 is preferably made of ABS or another hard plastic that is,for example, biocompatable. However, in alternative embodiments, thosecomponents may be made of other materials that provide similarfunctionality. In some embodiments, the first platform is placedadjacent to the patient's skin. The first platform can be mountedadjacent the patient's skin. In some embodiments, the first platform candirectly contact and sit against the patient's skin. A top retainingring 80 is configured to attach to the bottom platform 83 to retain thetop platform 81 and the middle layer 82 while allowing those two layersto rotate with respect to the bottom platform 83. Attaching can be inthe form of snap fitting, welding, gluing or any other method ofattachment. The top retaining ring 80 is preferably also made of ABS oranother hard plastic.

In some embodiments, the components of the valve assembly (e.g., the topplatform and the bottom platform) move with respect to one another. Asdiscussed, one platform can move with respect to another platform by arotational force. However, thru-holes that pass through each of theseplatforms can move with respect to one another by other suitable forcesby, for example, a force in a linear direction. The geometric shape ofthe components of the valve assembly may be adjusted to enablealternative forms of movement, for example, the platform, a retainer,and/or the elastomer layer may have a square, rectangular or othersuitable geometry the enables the thru-holes that pass through eachplatform (and optionally the elastomer layer) to alternately align andoffset from one another. In such configurations, one platform may bemoved linearly backward and forward with respect to the other platform(i.e., move linearly backward to provide the first position and movelinearly forward to provide the second position) or the movement can bein a single direction, for example.

In the illustrated embodiment, as best seen in FIGS. 9-11, the valveassembly 50 has protrusions 53 at its bottom that allows it to fasten torecesses 56 in the skin flange 55 to form the skin connector 60. The topface of the valve assembly preferably has a structure (e.g., the topplatform 81 has the cut-outs 52) for mating with a corresponding surfaceon the tube connector 65. The valve assembly 50 can be disassembled fromthe skin connector 60 by pushing the protrusions 53 at its bottom out ofthe recesses 56 in the skin flange 55. With significant force, manuallyor with a tool directed at the bottom of the recesses 56, the barbedprotrusions 53 can be freed from the recesses 56 in skin flange 55 andthe valve assembly 50 can be removed.

Removal of the valve assembly 50 from the skin connector 60 may berequired when a course of treatment is finished or in connection withvalve replacement due to wear, scheduled maintenance, cleanliness, orlength adjustment. Using a removable valve permits adjustment of thelength of the gastrostomy tube (e.g. after patient weight loss) tocompensate for a shortened stoma tract. After the valve assembly 50 isremoved, the tube is cut to a shorter length, and then the valve isreplaced, advantageously avoiding the need to replace the gastrostomytube.

In some embodiments, the valve assembly 50 is connected directly to thegastrostomy tube such that its bottom platform 83 sits against thepatient's skin. In this way, use of the skin flange 55 is avoided.Optionally, the bottom platform 83 has a smooth surface and does notcontain protrusions.

In some embodiments, an assembly includes a valve and a tube having afirst fluid pathway for disposal in a body of a patient. The valve has abottom platform, a top platform and a retainer. The bottom platform andthe top platform each has a thru-hole that passes therethrough. Aretainer retains the bottom platform in proximity to the top platform sothat the top platform can be moved with respect to the bottom platformbetween a first open position that aligns the thru-holes of the bottomand top platforms and a second closed position that offsets thethru-holes of the bottom and top platforms. The proximal end of the tubedisposed in a patient's body is mated with the thru-hole in the bottomplatform. A second tube that is external to the patient's body has asecond fluid pathway. The second fluid pathway can supply water or otherfluid to the assembly. A distal end of the second tube is adjacent thethru-hole in the top platform. The first fluid pathway and the secondfluid pathway join to form a single fluid pathway. When the valve ispositioned in the first position, the open position, the two thru-holesalign to provide access through the single fluid pathway. In the secondposition, the closed position, the thru-holes offset to provide a fluidtight seal and to prevent access through the fluid pathway. In someembodiments, each of the tube in the patient's body, the two thru-holes,and the external tube has a substantially similar internal diameter,thus the flow of fluid through this single fluid pathway issubstantially consistent, i.e., it is not restricted by a changinginternal diameter. In some embodiments, the top platform is moved in asubstantially linear direction with respect to the bottom platform. Insome embodiments, placement of the valve in the second position, theclosed position, offsets the thru-holes to provide a fluid tight sealand to prevent access through the fluid pathway when the external tubeis disconnected from the tube in the patient's body. In someembodiments, in order to disconnect the external tube from the valve thevalve must first be positioned in the second position, the closedposition.

Due to protrusions 66 on the contacting surface of the tube connector 65being configured to mate and mechanically couple with the cut-outs 52 onthe valve assembly 50 at a rotational distance of approximately 120°from the “open” position of valve assembly 50, fluid will not leak outof valve assembly 50 during tube connector 65 removal (i.e. disc 68 isalways covering the passageway of skin connector 60 prior to removal.)

For a gastrostomy tube designed to aspirate food from a full stomach(i.e. larger diameter to accommodate food particles,) the fluid pressuremay be higher than traditional feeding tubes, and the illustrated valveembodiments can withstand such higher pressures without leaking. Theillustrated valve embodiments are also designed to provide a large,uniform lumen from the tube through the valve. The rotational gasketconfiguration allows sealing of the tube without restricting the lumendimension when the valve is in the “open” position, thereby minimizingthe probability of tube clogging during food aspiration.

In one embodiment, referring to FIGS. 11-12, the skin connector 60 skinflange 55 has a thru-hole 57. The thru-hole 57 can be shaped tocomplement the gastrostomy tube when an end of the gastrostomy tube isinterested in the thru-hole 57. The bottom platform 83 can include spout511 (FIG. 12B) that, for example, surrounds the thru-hole 54. The spout511 of the thru-hole 54 can be sized to enter the lumen of thegastrostomy tube. For example, an end of the gastrostomy tube ispositioned so that the spout 511 of the thru-hole 54 enters its lumenand a portion of the gastrostomy tube is compressed between the spout511 and the thru-hole 57 of the skin flange 55. The thru-hole 57 of theskin flange 55 can be shaped to improve compression of the gastrostomytube, for example, the thru-hole 57 can have a funnel shape. In oneembodiment, the outer diameter of the spout 511 is the same as the innerdiameter of the proximal end of the gastrostomy tube. The shape of thethru-hole 57 can be selected according to the shape of the spout 511surrounding the thru-hole 54 of the bottom platform 83. Compression ofthe spout 511 against the thru-hole 57 can create a water-tight seal. Inone embodiment, at least a portion of the gastrostomy tube is made froma hydrophobic gasket material such as, for example, ePTFE. The portionof the gastrostomy tube containing a hydrophobic gasket material may becompressed between the spout 511 and the thru-hole 57 thereby forming awater-tight seal that prevents leakage of the gastrostomy tube. Inanother embodiment, the thru-hole 57 defined by the flange 55 has aninside surface with a thread that complements a helical supportstructure disposed on at least a portion of an outside surface of thegastrostomy tube. Support for a gastrostomy tube having a helicalsupport structure and/or employing ePTFE my be found in U.S. patentapplication Ser. No. 11/824,953 entitled “Shunt Apparatus for TreatingObesity by Extracting Food” by Solovay et al., which is incorporated byreference. In embodiments where the skin connector 60 includes a spout511 surrounding the thru-hole of the bottom platform 83 and/or theflange has an inside surface with a thread the complements a helicalsupport structure on the gastrostomy tube, removal of the valve requiredwhen treatment is finished or in connection with valve replacement canrequire additional steps. For example, prior to or after unfasteningprotrusions of the valve 50 from the flange 55 the spout 511 is removedfrom the lumen of at the proximal end of the gastrostomy tube. Inanother example, prior to or after unfastening protrusions of the valve50 from the flange 55 the valve 50 is rotated in a direction oppositethe helical support disposed on the gastrostomy tube thereby to removethe valve 50 from the gastrostomy tube.

Referring to FIGS. 11-13, in one embodiment, a proximal end of agastrostomy tube is mated with a thru-hole in the bottom platform of askin connector 60. The bottom platform 83 is placed adjacent to thepatient's skin, optionally, a portion of the skin connector's 60 flange55 is between the bottom platform 83 and the patient's skin. The skinconnector 60 can be placed adjacent to the patient's skin. The skinconnector 60 is rotated to a first position to cause the thru-hole 51that passes through the top platform 81 to substantially align with thethru-hole 54 in the open position to provide access to the fluid pathwayfor a first period of time. When the skin connector 60 is in the firstposition, the patient's stomach contents can be aspirated through thegastrostomy tube. Rotating the skin connector 60 to the first positionavoids restriction of the gastrostomy tube thereby aiding aspiration.The skin connector 60 is rotated to a second position to cause thethru-hole 51 to be offset from the thru-hole 54 to provide a fluid tightseal to the proximal end of the gastrostomy tube and to prevent accessto the fluid pathway for a second period of time.

In some embodiments, a proximal end of a tube other than a gastrostomytube is mated with a thru-hole 54 in the bottom platform 83 and thebottom platform 83 is placed adjacent to the patient's skin. Providingthe valve 50 in the first position provides access to a fluid pathway inthe tube during a first period of time and providing the valve 50 in thesecond position provides a fluid tight seal to the proximal end of thetube and access to the tube's fluid pathway is prevented during a secondperiod of time.

FIGS. 13A and 13B depict a tube connector 65 that is connected at theupper end of the patient line 20. The tube connector 65 is designed tomate with the skin connector, and protrusions 66 on the contactingsurface of the tube connector 65 are configured to mate with thecut-outs 52 on the valve assembly 50 (both shown in FIG. 9B). The bodyof the tube connector 65 is preferably constructed of a hard plasticsuch as ABS. The contacting surface of the tube connector 65 ispreferably implemented using a disc 68 made of an elastomeric materialsuch as silicone, with a biased thru-hole 67 that is dimensioned andpositioned to match the thru-hole of the skin connector. In theillustrated embodiment, the tube connector 65 has a ridge 71 around theperimeter of its contacting surface that is configured to fit into amating surface of the skin connector (i.e., the valley 61 around theperimeter of the skin connector 60, shown in FIG. 10C). The outersurface of the illustrated tube connector also has a handle 69 forgrasping by the user and a barbed hollow protrusion 70 that is in fluidcommunication with the thru-hole on the contacting surface for fasteningto the patient line tubing.

Referring now to FIGS. 10C and 12-14, when the tube connector 65 and theskin connector 60 are not mated, the valve assembly 50 on the skinconnector 60 is in a “closed” position, with the thru-hole 51 in the topplatform 81 and the middle layer 82 oriented out of phase with respectto the thru-hole 54 in the bottom platform 83. To connect the tubeconnector 65 and the skin connector 60, the thru-hole 67 of the tubeconnector is aligned with the thru-hole 51 in the top platform 81 of thevalve assembly 50. The tube connector 65 is then turned by grasping thehandle 69 and turning it clockwise. When this happens, the biasedthru-hole 51 in the top platform 81 and the middle layer 82 and thethru-hole 67 in the tube connector 65 will all rotate together intoalignment with the thru-hole 54 in the bottom platform 83 of the valveassembly 50, thereby opening a passage to the gastrostomy tube. Rotatingthe tube connector 65 clockwise also engages mating features 66 on thetube connector with corresponding cut-outs 52 on the valve assembly 50(shown in FIG. 9B) to lock the tube connector 65 to the skin connector60. The fluid pathway of the patient line 20 of the tube connector 65can join with the fluid pathway of the gastrostomy tube 45 that connectsto the skin connector 60 thereby providing a single fluid pathway.

After the passage is open, removal of ingested material from thepatient's stomach is performed, as described above (optionally inalternation with the infusing of liquids into the patient's stomach).Subsequently, the patient or practitioner rotates the tube connector 65counterclockwise, which causes the thru-hole 67, the biased thru-hole 51in the top platform 81, and the middle layer 82 to all rotate togetheraway from the thru-hole 54 in the bottom platform 83 of the valveassembly 50, to the position shown in FIG. 14A, thereby closing thevalve in the skin connector 60. The tube connector 65 can then be pulledaway from the skin connector 60.

Referring now to FIGS. 10-11, the skin connector 60 is preferablyconstructed with an outer skirt 58 composed of a soft, compliantmaterial (e.g. elastomer, foam, etc.) that tapers the fully assembledlow-profile skin-port towards the skin to provide a more aestheticappearance, to prevent the skin connector 60 from catching on the user'sclothing, and to serve as a bumper against applied stresses. Inalternative embodiments, the skin connector 60 and tube connector 65 canbe configured in various other forms and/or can use different materialsto optimize various characteristics. For example, both the skinconnector 60 and tube connector 65 can be made with an oblong shape.More specifically, one or more of the top platform, the bottom platform,the disk, and the retaining ring (i.e., the retainer) have an oblongshape. The mating features and turning of the valve can be actuated byalternate means that will be apparent to persons skilled in the relevantarts, including but not limited to thumbwheel mechanisms, scissormechanisms, etc. When mounted on the surface of the patient's skin, theskin connector 60 and/or the combination of the skin connector 60 matedto the tube connector 65 sits above the patient's skin at a distancethat measures from about 5 mm to about 20 mm, or from about 7 mm toabout 9 mm. Thus, the overall height of the skin connector 60 and/or thecombination of the skin connector mated to the tube connector 65 rangesfrom about 5 mm to about 20 mm, or from about 7 mm to about 9 mm. It isdesirable for the skin connector 60 and/or the skin connector 60 matedto the tube connector 65 to have a low-profile (i.e., a small distancethat measures from the patient's skin). Having a low-profile enables apatient to discretely wear the valve and discretely use the system toremove ingested material from the patient's stomach

One potential side-effect of aspirating food from the stomach islowering of electrolytes, such as potassium. The removal of hydrochloricacid (HCl) from the stomach along with food particles can cause thehuman body to excrete potassium to maintain a charge balance, andexcretion of too much potassium can cause hypokalemia. One method forpreventing hypokalemia is to give the patient potassium supplements anda proton pump inhibitor.

Another method for preventing hypokalemia is to selectively remove HClfrom the extracted material, and return it to the patient's stomach, inorder to prevent electrolyte imbalance and obviate the need foradditional therapeutics. To achieve acid return to the stomach, thedevice may be configured with one or more semi-permeable filters thatselectively screen out waste product and retain HCl for return to thestomach. Examples of suitable filters include mechanical filters,chemical filters, ionic membranes (e.g. anionic exchange membrane,cationic exchange membrane, bipolar membrane), and electrochemicalfiltrations systems (or a combination of the above).

One way to implement food evacuation with the return of acid to thestomach is by using two filters in series. The first filter, orpre-filter, separates food particles from the fluid. Examples ofsuitable filters for performing this function include mechanical filterslike standard glass-fiber or cellulose filters that selectively removesolids above a specified particle size, leaving “waste” fluid. Asuitable porosity for such a filter is 2.5 μm porosity. The secondfilter removes hydrochloric acid from the pre-filtered fluid. Examplesof suitable filters for performing this function include semi-permeablemembranes, or an anionic exchange membrane (e.g. NEOSEPTA™, Tokuyama,Japan).

FIG. 7A depicts a first embodiment for returning acid to the stomach. Asiphon effect or a pump is used to force evacuated stomach contentsthrough the pre-filter 110 and into one compartment 122 of a dualchamber container 120, which is separated from the other compartment 126by an anionic exchange membrane 124. The second chamber 126 containsdeionized water. The difference in ionic concentration between the dualchambers of the cell 120 will drive a diffusion dialysis process tooccur in which the Cl⁻ and H⁺ ions from hydrochloric acid selectivelytransfer across the membrane 124 into the water filled chamber 126. Thewaste fluid can then be released to exit to the toilet, and a pump 130can then be actuated to force the HCl and water solution back into thepatient's stomach. FIG. 7B depicts an alternative embodiment that issimilar to the FIG. 7A embodiment, but adds a separate water infusionsubsystem 140 to allow the subject to continue to flush and siphon thestomach while the diffusion dialysis process is occurring. More complexfiltration system can also be used, including but not limited toelectrodialysis, or an anode and a cathode to separate charged ions inan electrophoresis like fluid suspension. The electrofiltration processcould potentially decrease the time to remove the HCl from the wasteproduct.

Repeated removal of food from a patient's stomach to achieve weight lossrequires close medical supervision to avoid complications (e.g., a dropin electrolyte levels). It may therefore be desirable for the physicianto ensure that the patient returns for follow-up and blood testing toavoid improper use of the device, or at a minimum have data that revealsthe patient compliance with proper use of the system. A shut-offmechanism may be built into the system to ensure that the patientreturns for such follow-up. The shut-off mechanism preferably operatesbased on some measurement of usage such as the passage of time (e.g., todisable the device after one month), the number of cycles of use (e.g.,to disable the device after 90 uses), or the volume of extracted matter(e.g., to disable the device after 50 liters of material have beenremoved).

The measurement of usage may be implemented by mechanical or electricalmeans, as will be appreciated by persons skilled in the relevant arts(e.g., using a mechanical counter such as a multi-decade gearedmechanism that is incremented using a cam-actuated sprocket, or anelectrical counter that is incremented by a suitable sensor). Suitableevents that can be used to increment the count include, but are notlimited to, the connection of a water bottle to the system, theconnection of the tube connector to the skin connector, etc. Theshut-off mechanism may also be implemented by mechanical or electricalmeans. One example of a suitable mechanical shut-off mechanism is apreloaded spring mechanism that, when actuated, blocks fluid from movingthrough one of the system's tubes. An example of a suitable electricaldevice for implementing shut-off is a solenoid actuated valve, and awide variety of alternatives will be apparent to persons skilled in therelevant arts. The shut-off mechanism may be designed to permanentlydisable the device, in which case the patient would have to obtain a newdevice to continue using the system. Alternatively, it may be configuredto be resettable by a doctor (e.g., using an electronic shut-offmechanism that can be reset by entry of a password or a biometric keysuch as a fingerprint detector). After the patient is examined by thedoctor (e.g., using blood tests to confirm healthy electrolyte levels),the doctor could provide a new device or reset the shut-off mechanism.

One application of some of the above-described embodiments is toimplement a method of removing ingested food from a patient's stomachvia a gastrostomy tube that passes through the patient's abdominal wallinto the patient's stomach. This method includes the steps of: (a)siphoning a first portion of the ingested food out of the patient'sstomach via the gastrostomy tube; (b) infusing liquid into the patient'sstomach via the gastrostomy tube; and (c) siphoning at least some of theinfused liquid out of the patient's stomach via the gastrostomy tube,together with a second portion of the ingested food. Optionally, thismethod may further include the steps of: (d) infusing liquid into thepatient's stomach via the gastrostomy tube; and (e) siphoning at leastsome of the infused liquid out of the patient's stomach via thegastrostomy tube, together with a third portion of the ingested food,wherein step (d) is performed after step (c), and wherein step (e) isperformed after step (d).

Another application of some of the above-described embodiments is toimplement an apparatus for removing food from a patient's stomach via agastrostomy tube that passes through the patient's abdominal wall intothe patient's stomach. This apparatus includes: a connector configuredto connect to a proximal end of the gastrostomy tube with a fluid-tightconnection; a first fluid path provided between the connector and adrain port, configured to permit siphoning or pumping food from thepatient's stomach out to the drain port; a second fluid path providedbetween the connector and an input port, configured to permit infusionof liquid from the input port into the patient's stomach; and a fluidcircuit configured to alternately (a) open the first fluid path during afirst interval of time to permit siphoning or pumping food out of thepatient's stomach and (b) open the second fluid path during a secondinterval of time to permit infusion of the liquid in the reservoir intothe patient's stomach.

Another application of some of the above-described embodiments is toimplement a method of removing ingested material from a stomach of apatient fitted with an external gastrostomy connection to the stomach.This method includes: coupling a siphon tube to the connection so as tocreate a siphon system having an aggregate length in excess of 25 cm;and draining content of the stomach through the siphon tube.

Another application of some of the above-described embodiments is toimplement a method of removing ingested material from a stomach of apatient fitted with an external gastrostomy connection to the stomach.This method includes the steps of: pumping a fluid through theconnection into the stomach to increase fluid in the stomach withoutingestion of fluid; and draining content of the stomach through theconnection. Optionally, the fluid may include one or more of thefollowing: water, a nutrient, a medication, and returned gastric juices.

Another application of some of the above-described embodiments is toimplement an apparatus for removing ingested material from a stomach ofa patient fitted with an external gastrostomy connection to the stomach.This apparatus includes: a fluid source for infusing fluid into thestomach through the connection; and a drain line for draining content ofthe stomach received from the connection. Optionally, a siphon system isused for passively draining content of the stomach, preferably usingflat tubing. Optionally, a pump may be coupled to the fluid source forpumping fluid through the connection into the stomach.

Another application of some of the above-described embodiments is toimplement a method of removing ingested food from a patient's stomachvia a gastrostomy tube that passes through the patient's abdominal wallinto the patient's stomach. This method includes the steps of: (a)extracting a portion of the matter contained in the patient's stomachvia the gastrostomy tube; (b) removing stomach acid from the matterextracted in the extracting step; and (c) returning the stomach acidremoved in the removing step to the patient's stomach via thegastrostomy tube. Optionally, the removing step includes the steps of:(i) filtering out solid portions from the matter extracted in theextracting step; and (ii) filtering a liquid resulting from step (i)using a semi-permeable membrane or an anionic exchange membrane. In thisapplication, the extracting step may be implemented by siphoning orpumping.

Another application of some of the above-described embodiments is toimplement an apparatus for removing food from a patient's stomach via agastrostomy tube that passes through the patient's abdominal wall intothe patient's stomach. This apparatus includes: a connector configuredto connect to a proximal end of the gastrostomy tube with a fluid-tightconnection; a filter configured to separate stomach acid from othermatter; a first path from the connector to the filter, configured toroute matter extracted from the patient's stomach into the filter; apump configured to pump stomach acid that has been separated by thefilter back into the patient's stomach; and a second path configured toroute the other matter to a waste outlet. In this application, thematter extracted from the patient's stomach may be routed into thefilter by pumping or siphoning. Optionally, this apparatus may furtherinclude a reservoir configured to hold liquid and a pump configured topump the liquid from the reservoir into the patient's stomach via theconnector.

Another application of some of the above-described embodiments is toimplement a method of removing ingested food from a patient's stomachvia a gastrostomy tube that passes through the patient's abdominal wallinto the patient's stomach. This method includes the steps of: providingan apparatus for siphoning or pumping ingested food out of the patient'sstomach via the gastrostomy tube; and limiting the number of times thatthe siphoning or pumping operation can be performed by the apparatus.The number of times that the siphoning or pumping operation can beperformed may be limited by a variety of factors such as (a) elapsedtime from a first use, (b) how many times siphoning or pumping of foodhas been performed, (c) how many times the apparatus has been connectedto the gastrostomy tube, or (d) the volume of matter that has beenextracted from the patient's stomach. Optionally, this method mayfurther include the step of infusing liquid into the patient's stomachvia the gastrostomy tube, wherein the infusing step is performed inalternation with the siphoning or pumping.

Another application of some of the above-described embodiments is toimplement an apparatus for removing food from a patient's stomach via agastrostomy tube that passes through the patient's abdominal wall intothe patient's stomach. This apparatus includes: a connector configuredto connect to a proximal end of the gastrostomy tube with a fluid-tightconnection; and a first fluid path provided between the connector and adrain port, configured to permit, for a limited number of times only,siphoning or pumping food from the patient's stomach out to the drainport. The number of times that the siphoning or pumping can be performedmay be limited by a variety of factors such as (a) elapsed time from afirst use, (b) how many times siphoning or pumping of food has beenperformed, (c) how many times the apparatus has been connected to thegastrostomy tube, or (d) the volume of matter that has been extractedfrom the patient's stomach. Optionally, this apparatus may furtherinclude: a reservoir for holding liquid to be infused into the patient'sstomach; a second fluid path from the reservoir to the connector,configured to permit infusion of the liquid in the reservoir into thepatient's stomach; and a fluid circuit configured to alternately (a)open the first fluid path during a first interval of time to permitsiphoning or pumping food from the patient's stomach and (b) open thesecond fluid path during a second interval of time to permit infusion ofthe liquid in the reservoir into the patient's stomach.

Note that while the system is described herein in the context ofremoving the ingested material from the patient's stomach, it can alsobe used to remove the ingested material from other portions of thepatient's upper digestive tract (e.g., the jejunum).

Although the above discussion discloses various exemplary embodiments ofthe invention, it should be apparent that those skilled in the art canmake variations and modifications that will achieve some of theadvantages of the invention without departing from the true scope of theinvention. Accordingly, other embodiments are within the scope of thefollowing claims.

1-44. (canceled)
 45. A valve assembly for alternately providing andpreventing the passage of fluid and food through a fluid pathwaycomprising: a bottom platform having a first thru-hole biased to onequadrant that passes therethrough; a top platform having a secondthru-hole biased to one quadrant that passes therethrough; a middlelayer having a third thru-hole biased to one quadrant that passestherethrough, the middle layer comprising an elastomeric material andbeing sandwiched between the bottom platform and the top platform; and aretainer configured to retain the bottom platform in proximity to themiddle layer and top platform such that the middle layer and topplatform can be moved together with respect to the bottom platformbetween a first position and a second position, wherein in the firstposition the first, second, and third thru-holes align to provide accessto the fluid pathway and in the second position the first, second andthird thru-holes are not aligned to provide a fluid tight seal and toprevent passage of fluid and food through the fluid pathway.
 46. Thevalve assembly according to claim 45, the bottom platform beingconfigured to sit against a patient's skin.
 47. The valve assemblyaccording to claim 45, the first, second and third thru-holes eachhaving a diameter from about 6 to about 8 mm.
 48. The valve assemblyaccording to claim 45, each platform having a diameter from about 3.5 toabout 7 times larger than diameter of the thru-hole that passestherethrough.
 49. The valve assembly according to claim 45, the middlelayer being sandwiched between the top platform and bottom platform witha force that is high enough to prevent leaks and yet low enough topermit movement of the middle layer with respect to the bottom platform.50. The valve assembly according to claim 45, the middle layer beingattached to the top platform.
 51. The valve assembly according to claim45, one platform being capable of moving with respect to the otherplatform by a rotational force.
 52. The valve assembly according toclaim 45, one platform being capable of moving in a substantially lineardirection with respect to the other platform.
 53. The valve assemblyaccording to claim 45, the valve assembly being configured to provideaccess to the fluid pathway without changing the internal diameter ofthe fluid pathway.
 54. An apparatus comprising: a valve assembly foralternately providing and preventing the passage of fluid and foodthrough a fluid pathway comprising: a bottom platform having a firstthru-hole biased to one quadrant that passes therethrough; a topplatform having a second thru-hole biased to one quadrant that passestherethrough, a middle layer having a third thru-hole biased to onequadrant that passes therethrough, the middle layer comprising anelastomeric material and being sandwiched between the bottom platformand the top platform; and a retainer configured to retain the bottomplatform in proximity to the middle layer and top platform such that themiddle layer and top platform can be moved together with respect to thebottom platform between a first position and a second position, whereinin the first position the first, second, and third thru-holes align toprovide access to a fluid pathway and in the second position the first,second and third thru-holes are not aligned to provide a fluid tightseal and to prevent passage of fluid and food through the fluid pathway;and a gastrostomy tube having a distal end and a proximal end; the firstthru-hole of the valve assembly being mated with the proximal end of thegastrostomy tube.
 55. The apparatus according to claim 54, the fluidpathway comprising a uniformly sized lumen extending from a gastrostomytube through the valve assembly.
 56. The apparatus according to claim55, the lumen having a sufficiently large diameter to accommodate foodparticles.
 57. An apparatus for providing and preventing access to afluid pathway of a gastrostomy tube that passes through a patient'sabdominal wall into the patient's stomach, the apparatus comprising: afirst connector comprising a valve assembly, the valve assemblycomprising: a first platform having a first thru-hole biased to onequadrant that passes therethrough, the first platform being mounted to agastrostomy tube so as to remain stationary with respect to thegastrostomy tube and so that a fluid pathway is established between thefluid pathway of the gastrostomy tube and the first thru-hole, a secondplatform having a second thru-hole biased to one quadrant that passestherethrough, a third platform having a third thru-hole biased to onequadrant that passes therethrough, the third platform being sandwichedbetween the first and second platforms and being fixed with respect tothe second platform such that the third thru-hole is aligned with thesecond thru-hole, and a retainer that retains the first platform inproximity to the second platform such that the second platform can berotated with respect to the first platform between a first positionwherein the first and second thru-holes align to provide access to thefluid pathway of the gastrostomy tube and a second position wherein thefirst and second thru-holes offset to prevent access to the fluidpathway of the gastrostomy tube, the connector being configured forflush mounting on a patient's skin and having a low profile with respectto the patient's skin.
 58. The apparatus of claim 57, the firstconnector further comprising a skin flange, the skin flange beingcapable of interfacing with the first platform, sitting flush against apatient's skin and being connected to a gastrostomy tube positioned in apatient.
 59. The apparatus of claim 58 further comprising one or moreprotrusions disposed on the first platform that fasten to one or morecomplementary recesses in the skin flange.
 60. The apparatus of claim 57further comprising: a second connector having a disk defining a diskthru-hole sized and positioned to complement the first and secondthru-hole and one or more protrusions that removably couple to one ormore structures disposed on the first connector.
 61. The apparatus ofclaim 60 where the second connector further comprises a ridge configuredto mate with a valley on the first connector.
 62. The apparatus of claim60 wherein the second connector further comprises a tube having a secondfluid pathway that couples to the disk thru-hole.
 63. The apparatus ofclaim 62 wherein the fluid pathway and the second fluid pathway arejoined when the first and second thru-holes align in the first position.64. The apparatus of claim 60 wherein the first and second thru-holesalign in the first position to provide access to the fluid pathway whenthe second connector is coupled to the first connector.
 65. Theapparatus of claim 60 wherein the first and second thru-holes are offsetin the second position to prevent access to the fluid pathway when thesecond connector is separate from the first connector.
 66. The apparatusof claim 57 wherein aligning the first and second thru-holes in thefirst position avoids restriction of the gastrostomy tube.
 67. Theapparatus of claim 57 wherein the first platform further comprises aspout surrounding at least a portion of the first thru-hole, the spoutbeing sized to enter the lumen at the proximal end of the gastrostomytube.
 68. The apparatus according to claim 57, the first, second andthird thru-holes each having a diameter from about 6 to about 8 mm. 69.The apparatus according to claim 57, the first, second and thirdplatforms each having a diameter from about 3.5 to about 7 times largerthan the diameter of the thru-hole that passes therethrough.
 70. Theapparatus according to claim 57, the third platform being sandwichedbetween the first platform and second platform with a force that is highenough to prevent leaks and yet low enough to permit movement of thethird platform with respect to the first platform.
 71. The apparatusaccording to claim 57, the third platform comprising an elastomericmaterial.
 72. The apparatus according to claim 57, the valve assemblybeing configured to provide access to the fluid pathway without changingthe internal diameter of the fluid pathway.
 73. The apparatus of claim57, wherein the low profile measures between about 5 and about 20 mm.74. The apparatus of claim 57, wherein the low profile measures betweenabout 7 and about 9 mm.
 75. The apparatus of claim 57, wherein the firstplatform directly contacts the patient's skin.
 76. The apparatus ofclaim 57, further comprising an outer skirt that surrounds the firstconnector and tapers down towards the patient's skin at the periphery ofthe outer skirt.
 77. The apparatus of claim 76, wherein the outer skirtcomprises a soft, compliant material.
 78. The apparatus of claim 76,wherein the outer skirt comprises an elastomer.
 79. The apparatus ofclaim 76, wherein the outer skirt comprises a foam material.